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Utilizing External Collaboration To Accelerate Vaccine Development Utilizing External Collaboration To Accelerate Vaccine Development

Securing a partner to serve as an extension of Janssen’s Biotherapeutics Development API-Large Molecule team was essential to reducing both risk and the time needed for delivery of critical clinical supplies.

Efficient Cleaning-In-Place Methods For Protein-Based Antibody Affinity Chromatography Resins Efficient Cleaning-In-Place Methods For Protein-Based Antibody Affinity Chromatography Resins

This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.

BioProcess Containers – Materials Of Construction

Several characteristics are important to the performance of BPCs, including biological compatibility, physical and mechanical properties, and extractables and leachables (E&L).

The Future Of BioManufacturing

The biomanufacturing industry is undergoing a major shift, from single-product processes and stainless steel infrastructure to flexible, multi-product facilities using single-use technology.

Broaden Analysis Of Compound Factors For Predictive Solubility Solutions

Developed by the FDA, the Biopharmaceutics Classification System helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing.

The Race To Phase III: A Cautionary Tale Of Scalability

Follow the paths of two companies as they learn how a science-led, risk-based development approach yields a more successful outcome in the long run.

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A Wake-Up Call For APAC: FDA Requires Electronic Submissions By 2017

The demand for generic drugs is skyrocketing. According to the US FDA, nearly 8 in 10 prescriptions filled in the United States are for generic drugs. Generic drugs can be considerably less expensive while typically providing the same level of effectiveness as brand name therapeutics. The demand is intensified by initiatives such as the Affordable Care Act that intend to lower the cost of national healthcare by compelling a move toward less expensive generics and biosimilars.

How To Kick-Start Your CAPA Process

The medical device industry faces the challenge of delivering safe and cost-effective products on time, every time. By Ken Peterson

The Drugs To Watch: New Report Identifies 20 Of The Most Promising For 2014

The end of 2013 saw numerous drugs change clinical phase or receive approval and launch, creating an exciting landscape for drugs to watch in 2014.  Whether it’s a new HIV drug gaining approval or the advancement of a rheumatoid arthritis therapy from phase II to phase III trials, The Ones to Watch, a quarterly report from Thomson Reuters, keeps a finger on the pulse of the most promising drugs by mining strategic data from CortellisTM Competitive Intelligence.


Using these insights, Thomson Reuters analysts found that orphan drugs feature prominently in the market, with the recent launch of two drugs for orphan cancer indications: GazyvaTM and ValchlorTM, and important phase transitions for several others. In the US there have been nearly 250 labeled indications relating to orphan drug designations approved since the enactment of the Orphan Drug Act in 1983. Cortellis Competitive Intelligence describes over 800 drugs that have received at least one orphan designation.

Moving To A Modern Cold Chain Data Monitoring System

In the world of pharmaceutical supply chains, where cost reduction is king and a growing number of products are temperature controlled – collecting, communicating and analyzing temperature and logistics data is critical to success.

More Pharma Outsourcing App Notes & Case Studies


Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.

About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.

About provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.

Louis Garguilo Articles



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